Je-Vax

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Je-Vax

WARNINGS

Adverse reactions to JE vaccine manifesting as generalized urticaria or
angioedema may occur within minutes following vaccination. A possibly related
reaction has occurred as late as 17 days after vaccination. Most reactions occur
within 10 days with the majority occurring within 48 hours.1 (See
ADVERSE REACTIONS section.)

Vaccinees should be observed for 30 minutes after vaccination and warned
about the possibility of delayed generalized urticaria, often in a generalized
distribution or angioedema of the extremities, face and oropharynx, especially
of the lips.1

Vaccinees should be advised to remain in areas where they have ready access
to medical care for 10 days after receiving a dose of JE vaccine. Vaccinees
should be instructed to seek medical attention immediately upon onset of any
reaction.1

Persons should not embark on international travel within 10 days of JE-VAX (japanese encephalitis virus vaccine inactivated)
immunization because of the possibility of delayed allergic reactions.1

Persons with a past history of urticaria after hymenoptera envenomation,
drugs, physical or other provocations, or of idiopathic cause appear to have
a greater risk of developing reactions to JE vaccine (relative risk 9.1, 95%
confidence interval 1.8 to 50.9).6 This history should be considered
when weighing risks and benefits of the vaccine for an individual patient. When
patients with such a history are offered JE vaccine, they should be alerted
to their increased risk for reaction and monitored appropriately. There are
no data supporting the efficacy of prophylactic antihistamines or steroids in
preventing JE vaccine-related allergic reactions.1

Another case control study consisting of 5 cases and 15 controls identified
an increased risk of hypersensitivity reactions to JE vaccine in individuals
who had unusual alcohol consumption during the two days following vaccination
(p = 0.005).7 Recipients should be advised to avoid more than
the usual alcohol intake during the 48 hours following JE vaccination.

In the same study an increased risk for hypersensitivity reactions was seen
in individuals who received other vaccines within the 7-day period prior to
receipt of JE vaccine. Where possible JE vaccine should be administered concurrently
with other vaccines.7

Epinephrine and other medications and equipment to treat anaphylaxis should
be available at vaccine administration centers.

PRECAUTIONS

General

Epinephrine Injection (1:1000) must be immediately available should an acute anaphylactic reaction occur due to any component of the vaccine.

Prior to injection of any vaccine, all known precautions should be taken to
prevent adverse reactions. This includes a review of the patients history
with respect to possible sensitivity to this vaccine, a similar vaccine or allergic
disorders in general. (See CONTRAINDICATIONS
section).

A separate, sterile syringe and needle or a disposable unit should be used for each patient to prevent transmission of infectious agents from person to person. Needles should not be recapped and should be disposed of according to biohazard waste guidelines.

Although substantial neutralizing antibody titers are elicited by JE-VAX in
more than 90% of US travelers without history of prior JE immunization or of
prior exposure to JE, the precise relationship between antibody level and efficacy
has not been established even though these titers persisted for at least two
years after immunization.8

The decision to administer JE vaccine should balance the risks for exposure
to the virus and for developing illness, the availability and acceptability
of repellents and other alternative protective measures, and the side effects
of vaccination.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been performed to evaluate carcinogenicity, mutagenic potential, or impact on fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with Japanese Encephalitis
Virus Vaccine. It is not known whether Japanese Encephalitis Virus Vaccine can
cause fetal harm when administered to a pregnant woman or can affect reproductive
capacity. Pregnant women who must travel to an area where risk of JE is high
should be immunized when the theoretical risks of immunization are outweighed
by the risk of infection to the mother and developing fetus. Japanese Encephalitis
Virus Vaccine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether JE-VAX (japanese encephalitis virus vaccine inactivated) is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when JE-VAX (japanese encephalitis virus vaccine inactivated) is administered
to a nursing woman.

Pediatric Use

SAFETY AND EFFECTIVENESS OF JE-VAX IN INFANTS UNDER ONE YEAR OF AGE HAVE
NOT BEEN ESTABLISHED. (See DOSAGE AND ADMINISTRATIONsection.)